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Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

This study is enrolling participants by invitation only.
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC. Identifier:
First received: April 19, 2010
Last updated: April 11, 2017
Last verified: April 2016
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).

Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Diffuse Well-differentiated Lymphocytic Lymphoma
B Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
Waldenstrom Macroglobulinemia
Burkitt Lymphoma
B-Cell Diffuse Lymphoma
Drug: PCI-32765
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia.

Resource links provided by NLM:

Further study details as provided by Pharmacyclics LLC.:

Primary Outcome Measures:
  • Adverse Events/ Safety Tolerability [ Time Frame: 30 days after last dose of study drug ]
    Frequency, severity, and relatedness of adverse events

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Frequency of tumor assessments done per standard of care ]
    Tumor response will be assessed per established response criteria. This study will capture time to progression-free survival

  • Duration of Response [ Time Frame: Time to disease progression ]
    Duration of response as measured by established response criteria for B cell lymphoma and chronic lymphocytic leukemia

  • Overall Survival [ Time Frame: Every 3 months (±7 days) until the end of study ]
    After disease progression, attempts to follow for subject survival status (including cause of death) by clinic visit, or phone contact as well as collection of subsequent anti cancer therapy should be performed once every 3 months (±7 days) until the end of study.

  • Tolerability [ Time Frame: 30 days after last dose of study drug ]
    Long term tolerability as measured by treatment related SAEs and discontinuation of study treatment due to AEs.

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI-32765 Drug: PCI-32765
Dose based on parent protocol


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
  • Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria:

  • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
  • Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
  • Lactating or pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01109069

United States, California
Stanford, California, United States, 94305
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, New York
New Hyde Park, New York, United States, 11042
New York, New York, United States, 10065
Rochester, New York, United States, 14642-0001
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Oregon
Springfield, Oregon, United States, 97477
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77030
Tyler, Texas, United States, 75702
United States, Vermont
Burlington, Vermont, United States, 05405
United States, Washington
Vancouver, Washington, United States, 98684
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Study Director: Alvina Chu, MD Medical Monitor
  More Information

Additional Information:
Responsible Party: Pharmacyclics LLC. Identifier: NCT01109069     History of Changes
Other Study ID Numbers: PCYC-1103-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
Study First Received: April 19, 2010
Last Updated: April 11, 2017

Keywords provided by Pharmacyclics LLC.:
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Bruton's Tyrosine Kinase

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Burkitt Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders processed this record on April 28, 2017